Instruction For Use

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Pharmacological Committee Ministries of Health of Georgia

Registration number № R- 014514, № R-015768.

 

 

 

GA-40 is a complex of peptides, obtained from the ecologically pure plant material. GA-40 contains a biochemically purified standardized combination of plant-origin natural peptides.

Composition
Acting substance: 1 mg of GA-40.
Supplement substances: 45 mg sodium chloride,
13,5 mg potassium dihidrophosphate, pH 7,4

Form of Production
GA-40 is produced in the form of a lyophilized powder. The packing box contains 5 vials. Each vial contains 1 mg lyophilized powder of GA-40.

Pharmacological Group and Classification Code
Immunomodulator – code: LO3A; antineoblastic - code: L01C.

Pharmacological Properties
Preclinical and clinical trials show that the drug GA-40 is an immunomodulator and belongs to immunocorrectors of immunorehabilitation type. The drug GA-40 is characterized by direct anti-tumor and indirectly mediated by immunity anti-tumor action.

GA-40 possesses selective action. Unlike chemical preparations, GA-40 does not damage normal cells that define its safety action on any tissues and organs of the organism. GA-40 interacts with membrane DR receptors of death on the surface of the tumor cells and kills them by promoting apoptosis (programmed cellular death).

GA-40 causes normalization of p53, p21 functions, and blocking of the glutathione system of a tumor.

GA-40 causes activation of anti-tumor systems of immunity. GA-40 interacts with the specific membrane receptors located on the surface of mononuclear cells of immunity (monocytes, macrophages). As a result, changes appear in the structure of phosphatidylserine and activation of Ca2 +- of independent protein kinase C from a class of new or atypical and tyrosine protein kinases - Ca (PKCε), Ca2 +-dependent on protein kinases +Ca (PKCα,) and the tyrosine protein kinases. Protein kinases way leads (TPK) to activation of a transcription factor of NF-kB and its translocation in a nucleus. Activation of NF-kB is expressed in the increase of production of a factor of necrosis of a tumor (TNF-α), interferon - ү (INF-ү), activating the expression of specific genes. The mechanism of action of GA-40 is the cornerstone of the processes of activation of cells of immunity possessing the ability to destroy cancer cells: natural killer cells (NK-cell), T-cytotoxic cells, macrophages, and neutrophils.

The anti-tumoral action of GA-40 is also caused by its anti-angiogenesis property. GA-40 inhibits the release of vascular epithelial cell growth factor (VEGF) by cancer cells. GA-40 inhibits the development of new blood vessels or the process of neovascularization in malignant neoplasm and metastases and practically prevents the spread of metastases in the body via the blood circulatory system. GA-40 shows the expressed antioxidant and cytoprotective activity (neutralization of free radicals) that is especially important for the treatment of cancer patients by traditional methods and in the period of preventive treatment. An increase in liver GA-40 causes the decrease in serotonin, lactic and pyruvate acids, xanthine, uric acid, hydrogen peroxide, and oxygen with two unpaired electrons and hydrogen with one unpaired electron. The latter ones are free radicals, a high amount of which can be observed in the bodies of patients with malignant tumors, especially after radiotherapy and chemotherapy.

GA-40 has immunocorrective properties that make a correction of the immune status of the organism and restore the quantitative and functional indicators T and B of immune cellular systems i.e. T-helper cells, T-cytotoxic cells, T-killers (NK-cells), macrophages, and granulocytes. It regulates the correlation of T-helper and T-suppressor cells. It also regulates the indicators of immunoglobulin’s, stimulates the production of cytokines, including the tumor necrosis factor (TNF-a) and interferon’s (INF).

GA-40 restores the functional activity of stem hemopoietic cells too, normalizing the content of leukocytes, erythrocytes, neutrophils, thrombocytes, lymphocytes, and other blood-forming elements.

GA-40 provides for normalization of the blood biochemical indicators – total protein, albumin, globulin, urea nitrogen, creatinine, bilirubin, glucose, as well as certain enzymes such as alanine-aminotransferase (ALT), aspartate-aminotransferase (AST), γ-glutamine-transpeptidase (γ-GP), and alkaline phosphatase. The preparation renders a positive influence on the dynamic contents in the bloodstream of carcinoembryonic antigens (CEA), alpha-fetoprotein (AFP), prostate-specific antigen (PSA), as well as the blood contents in mineral compounds of sodium, calcium, potassium, and others.

Indications GA-40 is applied to:
* Malignant tumors

  • Monotherapy treatment with GA-40 is recommended at the early stages of tumor development. Permanent treatment of cancer patients with GA-40 is recommended, when the size of the tumor formation does not exceed 1 cm, it induces complete regression of the tumor and a full recovery of the patient.

  • Monotherapy treatment with GA-40 is recommended in patients suffering from cancer, who have exhausted all methods of standard treatment. Permanent and long-term treatment with GA-40 reduces pain, improves a general condition, increases energy and vitality, improves the degree of life, and significantly increases life span.

  • The use of GA-40 is recommended in combination with radiation and chemotherapy (before the therapy, in parallel with it and in the following period) for the achievement of high efficacy of treatment. The use of GA-40 in combination with radiation and chemotherapy increases the efficiency of treatment at its direct and anticancer action due to the immunity on tumor cells. Because detoxifying, antioxidant, and genoprotective properties of GA-40 significantly reduces the toxic effects of chemotherapy and radiation on the organism and protects it from the development of the formation of new tumors.

  • The use of GA-40 is recommended before and after surgical intervention for the achievement of high efficiency of treatment. The treatment with GA-40 before the surgery provides the normalization of the indices of the immune system, suspension of neovascularization processes, blocking the distribution of metastases, destroying of existing and hidden metastases, and as a result, the localization of the primary foci of malignant tumor in the organism occurs and it is protected from the further development of postoperative recurrences.

  • The use of GA-40 during leukemia is recommended in combination with radiation and chemotherapy. During acute and chronic myelogenous leukemia at the treatment with GA-40, the transformation of cancer cells into normal ones is observed and the improvement of formation of blood cells – hematopoietic processes, the toxic impact of chemotherapy on the organism reduces.

It may also be used:

  • ·  For leucosis - acute myeloid leukemia (AML) and chronic myeloid leukemia (CML) monotherapy or as adjuvant therapy.

  •  For the treatment of benign tumors (fibroid, myoma, adenoma, cystose, etc.).

  • During infection-inflammatory processes (pneumonia lobularis, bronchopneumonia, pulmonary tuberculosis, liver disorders (cirrhosis, hepatitis-C), chronic banal prostatitis, etc.)

  • Nontoxic preventive treatment for patients at risk (genetic predisposition coupled with environmental challenges), and those with precancerous lesions.·

  • For prophylaxis. It is recommended for persons above 40-50 age to carry out a course of treatment twice a year, to allow us to get rid of senile non-specific diseases, to reduce the risk of oncological diseases, and to create a state of the organism in which susceptibility to virus and other infectious diseases is reduced to a minimum.

Dosage and Method jf Application

In the instruction, you will learn how to prepare and get GA-40. Please read the instructions carefully and prepare the GA-40 injection solution according to it, select the dose and give the injection. The doctor will prescribe the appropriate dose of GA-40 depending on the patient’s weight.

• 1-50 kg body weight / 0,5 ml;

• 50-100 kg body weight / 1 ml;

• 100-150 kg body weight / 1,5 ml;     

• 150-200 kg body weight / 2,0 ml;

GA-40 is injected subcutaneously or intramuscularly, it is desirable into the buttock muscle with insulin syringe per 100 kg of body weight and below, and with 2 g syringe per 100 kg and above.

The injection is recommended to perform once a day after 6 pm. In severe cases, for intensive treatment course, the injection is recommended to perform twice a day - in the morning and evening with 12 hours intervals. The duration of one course of treatment makes up 25 days. The interval between courses is 10-14 days.

The treatment is continued until the complete regression of tumor or other diseases. In all the cases the course consists of at least 7 courses.

In severe forms of the disease, the intervals between the courses are not recommended.

For prevention or prophylaxis, the course of treatment (once a day) is repeated at intervals of 4-6 months

​Side Effects

In therapeutic dosage is non-toxic, with no side effects, it is possible to reveal hypersensitivity towards the components.

​Contraindications 

It is not revealed.

​Pregnancy and Breastfeeding 

Ga-40 is used during pregnancy and lactation with no contraindications.

Reference to "Withdrawal Syndrom" Risk Development

​The drug does not have "withdrawal syndrome".

​Special Instructions 

​Does not affect the ability to drive or work with machines.

Overdose

​Ga-40, a 40-fold therapeutic dose is completely safe for the body.

​Drug Interaction

​Compatible with all the drugs that are used in the above-mentioned diseases.

Condition and Term of Storage 

​It should be stored in a place protected from light at a temperature from  +10 to 20°C.

Shelf Life

​1 month after opening. 2 years unopened.

​Pharmacy Issuing Rule 

​Obtained a prescription.